Irritable Bowel SyndromeNCT00706758
Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome
A study testing IBS school and IBS-guidebook in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- IBS school and IBS-guidebook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2004to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 to 70 years old, with IBS according to the Rome II criteria
- Written informed consent
Who cannot join
- An organic GI disease and/or with another disease potentially affecting the GI symptoms
- Severe psychiatric disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention.
Read the detailed description
In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. We plan to include men and women 18 to 70 years old, with IBS according to the Rome II criteria, who are referred from physicians in primary care and secondary/tertiary care to participate in the study. The education will be held at the GI out patient clinic at Sahlgrenska University hospital in Gothenburg. A nurse, specialized in GI functional disorders will conduct an interview with each patient for about 30 minutes to collect additional information from the patients before inclusion. The patients will be informed about the positive results obtained in previous studies with both interventions, i.e. a structured patient education (IBS school) and a self-help guidebook. Patients with an organic GI disease and/or with another disease potentially affecting the GI symptoms were excluded. Likewise, patients with a severe psychiatric disease were excluded due to potential problems to participate in a group intervention. In order to allocate an equal number of patients to both of the interventions during the study, a number of up to 20 patients will be interviewed in a block during one week. After all these interviews the patients will be randomly divided into two groups with an equal number of patients in each group. The groups will then be randomized 1:1 to either start the IBS school within two to three weeks, or to receive the IBS Guidebook. The patients in the guidebook group will be offered to participate in the IBS school six months later, as part of the clinical routine at our unit (as requested by the ethics committee). The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention:
- Perceived knowledge about IBS
- IBS Severity Scoring System (IBS-SSS)
- IBS Quality of Life (IBSQOL)
- Visceral Sensitivity Index (VSI)
- The Hospital Anxiety and Depression Scale (HAD)
The interventions:
IBS school The IBS school is designed based on the self-efficacy theory , and the general theory of nursing. Moreover, the education is performed based on a biopsychosocial model considered to be important in functional GI disorders. The IBS-school consists of six sessions held once per week in a group setting with eight to ten patients in each group. Five different health care professionals (nurse, gastroenterologist, dietician, physiotherapist and psychologist) are involved in the education, in order to cover a wide spectra of issues related to IBS. Each of the professionals will hold one session for two hours where a lot of space is given for discussion in the group. This intervention has been described in detail previously (Ringström et. al. Submitted).
IBS Guidebook The IBS Guidebook consists of two booklets, written for IBS patients by one of the gastroenterologists in this study (MS). The booklets are detailed and cover the same areas of issues related to IBS as are covered in the structured education, namely pathophysiological mechanisms, GI and extra intestinal symptoms, the diagnostic workup, treatment options, food related issues, psychological and lifestyle factors.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- IBS school, IBS-guidebook
- Keywords
- Irritable bowel syndrome, Patient education
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBS schoolBehavioural
Structured patient group education
IBS-guidebookBehavioural
Written information - IBS-guidebook
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Structured patients group intervention - IBS school Receives: Behavioral: IBS school |
| 2 | Active comparator | Written information - IBS-guidebook Receives: Behavioral: IBS-guidebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on GI symptoms as measured by IBS-SSS
Measured: Basleline and 3 and 6 months
Secondary outcomes (1)
Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS.
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startAug 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Magnus Simrén, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706758
- Sponsor's protocol ID
- S487-02
- Status last verified
- Jun 2008
- First submitted
- 25 Jun 2008
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00706758
- Acronym / sponsor ID
- S487-02
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention.
Detailed description
In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. We plan to include men and women 18 to 70 years old, with IBS according to the Rome II criteria, who are referred from physicians in primary care and secondary/tertiary care to participate in the study. The education will be held at the GI out patient clinic at Sahlgrenska University hospital in Gothenburg. A nurse, specialized in GI functional disorders will conduct an interview with each patient for about 30 minutes to collect additional information from the patients before inclusion. The patients will be informed about the positive results obtained in previous studies with both interventions, i.e. a structured patient education (IBS school) and a self-help guidebook. Patients with an organic GI disease and/or with another disease potentially affecting the GI symptoms were excluded. Likewise, patients with a severe psychiatric disease were excluded due to potential problems to participate in a group intervention. In order to allocate an equal number of patients to both of the interventions during the study, a number of up to 20 patients will be interviewed in a block during one week. After all these interviews the patients will be randomly divided into two groups with an equal number of patients in each group. The groups will then be randomized 1:1 to either start the IBS school within two to three weeks, or to receive the IBS Guidebook. The patients in the guidebook group will be offered to participate in the IBS school six months later, as part of the clinical routine at our unit (as requested by the ethics committee). The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention:
- Perceived knowledge about IBS
- IBS Severity Scoring System (IBS-SSS)
- IBS Quality of Life (IBSQOL)
- Visceral Sensitivity Index (VSI)
- The Hospital Anxiety and Depression Scale (HAD)
The interventions:
IBS school The IBS school is designed based on the self-efficacy theory , and the general theory of nursing. Moreover, the education is performed based on a biopsychosocial model considered to be important in functional GI disorders. The IBS-school consists of six sessions held once per week in a group setting with eight to ten patients in each group. Five different health care professionals (nurse, gastroenterologist, dietician, physiotherapist and psychologist) are involved in the education, in order to cover a wide spectra of issues related to IBS. Each of the professionals will hold one session for two hours where a lot of space is given for discussion in the group. This intervention has been described in detail previously (Ringström et. al. Submitted).
IBS Guidebook The IBS Guidebook consists of two booklets, written for IBS patients by one of the gastroenterologists in this study (MS). The booklets are detailed and cover the same areas of issues related to IBS as are covered in the structured education, namely pathophysiological mechanisms, GI and extra intestinal symptoms, the diagnostic workup, treatment options, food related issues, psychological and lifestyle factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: IBS schoolStructured patients group intervention - IBS school |
| 2 | Active comparator | Behavioral: IBS-guidebookWritten information - IBS-guidebook |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women 18 to 70 years old, with IBS according to the Rome II criteria
- Written informed consent
Key exclusion criteria (2 listed)
- An organic GI disease and/or with another disease potentially affecting the GI symptoms
- Severe psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBS schoolStructured patient group education | Behavioural | 1 |
| IBS-guidebookWritten information - IBS-guidebook | Behavioural | 2 |
Primary outcome
Effect on GI symptoms as measured by IBS-SSS
Time frame: Basleline and 3 and 6 months
1 secondary outcome
Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS.
Time frame: Baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Simrén, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBS school and IBS-guidebook in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on GI symptoms as measured by IBS-SSS (time frame: Basleline and 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.